Protecting and empowering adults with capacity-affecting conditions to take part in health and health-related research

Abstract

Health research is essential if people are to enjoy the highest attainable standard of health and healthcare. Yet, persons with capacity-affecting conditions are routinely excluded from research, as they are often judged to lack the capacity to give consent. Focusing on the Mental Capacity Act England and Wales 2005 (MCA), which regulates research involving adults judged to lack capacity, we outline the provision of the MCA and then describe the process of ethical review designed to ensure compliance with these provisions; 2) present findings from interviews with members of the committees responsible for ethical review and with researchers, who have experience of working with the MCA; 3) discuss the implications of these findings for the inclusion of adults lacking capacity in research as well as drawing conclusions about the effectiveness of the MCA.

POINTS OF INTEREST

• Adults with capacity-affecting conditions are often judged as unable to give or withhold consent and are routinely excluded from participating in biomedical and clinical research.

• Denying this group an opportunity to participate in research reduces the possibility of them benefiting from both new treatments and improvements in healthcare.

• The Mental Capacity Act England and Wales 2005 provides a legal framework for involving adults with capacity-affecting conditions in research where consent is a legal requirement.

• Interviews with researchers and those responsible for ensuring the Mental Capacity Act England and Wales 2005 revealed that it is poorly understood and that there are no reliable means of ensuring the Act is fully implemented.

Keywords:

• Mental Capacity Act
• research
• equality
• health
• healthcare
• inclusion
• the Convention on the Rights of Persons with Disabilities

Acknowledgements

We are grateful to the Research Ethics Committee members and the researchers who agreed to be interviewed, and to the Nuffield Foundation for funding this research.

Disclosure statement

No potential conflict of interest was reported by the authors.

Additional information

Funding

Nuffield Foundation, grant number: OSP/43239